Biological navigation device

ABSTRACT

A biological navigation device that can be attached or integrated with an elongated element, such as a colonoscope, is disclosed. The device can be used for navigation through a biological lumen. The device can have an everting tube controllably tearable substantially in the direction of the long axis of the device. The elongated element can be deployed through a channel formed in the inner virtual space of the channel extending along the long axis.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of PCT Application Nos.PCT/US08/52535, filed 30 Jan. 2008; and PCT/US08/52542, filed 30 Jan.2008; which claim the benefit of U.S. Provisional Application Ser. Nos.60/887,319, filed 30 Jan. 2007; 60/887,323, filed 30 Jan. 2007; and60/949,219, filed 11 Jul. 2007, all of which are incorporated herein byreference in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The presented invention relates generally to devices for the explorationof luminal cavities. One such device example is an endoscope, which canbe used to explore body passages. Such passages typically include, butare not limited to, the GI tract, the pulmonary and gynecologicalsystems, urological tracts, and the coronary vasculature. Oneapplication is directed towards the exploration of the lower part of theGI tract, for example the large intestine or colon.

2. Description of the Related Art

Colonoscopy is a diagnostic and sometimes therapeutic procedure used inthe prevention, diagnosis and treatment of colon cancer, among otherpathologies. With colonoscopy, polyps can be harvested before theymetastasize and spread. With regular colonoscopies, the incidence ofcolon cancer can be substantially reduced.

A simplified typical large intestine or colon is shown in FIG. 1. Theanus 12 can provide entry into the colon for a colonoscopy. The colon 10extends from the rectum to the cecum 24 and has sigmoid 16, descending18, transverse 20 and ascending portions. The sigmoid colon is thes-shaped portion of the colon between the descending colon and therectum.

Colonoscopy typically involves the anal insertion of a semi-flexibleshaft. To typically navigate the colon, the forward few inches of tipare flexed or steered as the shaft is, alternately pushed, pulled, andtwisted in a highly skill-based attempt to advance to the end of thecolon: the cecum. The medical professional imparts these motions inclose proximity to the anus, where the device enters. Tip flexure hastypically been accomplished by rotating wheels—one that controls cablesthat move the tip right-left, and one that controls cables that move thetip up-down.

A shown in FIG. 2, colonoscopes typically utilize various conduits orchannels. The conduits or channels often contain elements that enablevision (e.g., fiber optics, CCD cameras, CMOS camera chips) and lighting(e.g., fiber optic light sources, high power LEDs (Light EmittingDiodes)), such as energy delivery and/or receipt conduits 26, 28 and 29.They have conduits that provide suction or pressurization, fluidirrigation, the delivery of instruments (e.g. for cutting, coagulation,polyp removal, tissue sampling) and lens cleaning elements (typically aright angle orifice that exits near the camera, such that a fluid flushprovides a cleansing-wash), such as conduits 30, 32, 34, 36, 38, 40 and42.

Colonoscopes include articulating sections at their tip, which allow theuser to position the tip. These articulating sections have rigid linkbodies that rotate relative to each other through the use of pins attheir connecting joints. As tensile cables pull from the periphery ofthe articulating sections, they impart torques, which rotate the linksections on their pins, articulating the tip section. The links areusually rotated by two or four tensile cables.

Typical commercially available colonoscopes are currently reusable.However, as disposable and other lower-cost colonoscopes are developed,these articulatable sections are no longer practical. Their high partcount creates total costs that are exorbitant for a lower cost,disposable device. The pivot pins can also fall out, which can create apatient danger. Their design geometries, while suited for long life,high cost, high strength metals elements, don't readily suit themselvesto the design goals of lower-cost and more readily mass-produced parts.

Suction can be utilized to remove debris or fluid. The colon can bepressurized to reconfigure the colon into an expanded cross-section toenhance visualization.

During advancement of the colonoscope through the colon, landmarks arenoted and an attempt is made to visualize a significant portion of thecolon's inside wall. Therapeutic actions call occur at any time, but aretypically performed during withdrawal.

Navigating the long, small diameter colonoscope shaft in compressionthrough the colon—a circuitous route with highly irregular anatomy—canbe very difficult. Studies have shown a learning curve for doctorsperforming colonoscopies of greater than two-hundred cases. Even withthe achievement of such a practice milestone, the cecum is often notreached, thereby denying the patient the potential for a full diagnosis.

During colonoscopy, significant patient pain can result. This istypically not the result of colon wall contact or of anal entry. Theprimary cause of pain is thought to be stretching and gross distortionof the mesocolon (the mesentery that attaches the colon to otherinternal organs). This is commonly referred to as ‘looping’ and is aresult of trying to push a long, small diameter shaft in compression asthe clinician attempts to navigate a torturous colon. While attemptingto advance the tip by pushing on the scope, often all that occurs isthat intermediate locations are significantly stretched and grosslydistorted. Due to this pain, various forms of anesthesia are typicallygiven to the patient. Anesthesia delivery results in the direct cost ofthe anesthesia, the cost to professionally administer, the costsassociated with the capital equipment and its facility layouts, and thecosts associated with longer procedure time (e.g., prep, anesthesiaadministration, post-procedure monitoring, and the need to have someoneelse drive the patient home). It has been estimated that forty percentof the cost of a colonoscopy can be attributed to the procedure's needfor anesthesia.

Cleaning of colonoscopes is also an issue. Cleaning is time consuming,and lack of proper cleaning can result in disease transmission. Cleaningcan utilize noxious chemicals and requires back-up scopes (some in usewhile others being cleaned). Cleaning also creates significantwear-and-tear of the device, which can lead to the need for moreservicing.

It would therefore be desirable to create a system that is lesspainful—possibly not even requiring anesthesia—is significantly easierto use, and does not require cleaning.

Everting tube systems have been proposed for use as colonoscopes.However, multiple challenges exist for everting systems. One typicalchallenge is the differential speed between the center lumen and thetip. For example, as the typical everting tube is advanced, the centerlumen of the colonoscope advances 2″ for every 1″ of eversion frontadvancement. When the center advances it moves only itself, whereas tipmovement advances material on both sides. Because there is this dualwall material requirement for tip advancement, two times as muchmaterial is required, so it inherently must travel at half the rate.

Anything that is in the center of the typical everting tube is ‘pressureclamped,’ as the tube's inner diameter collapses to no cross sectionalarea as the tube is pressurized. This can make it difficult to try tosolve the 2:1 problem in a typical everting tube by sliding elements inthe inner diameter or central region.

This 2:1 advancement issue and the pressure clamping can make itdifficult to locate traditional colonoscope tip elements at the evertingtip's leading edge. Given that the tube is often long and pressurized,it therefore often precludes the ability to create a functioning centerworking channel.

Another issue is internal drag. Material (e.g., tube wall) fed to thetip can cause increased capstan drag, for example the overall systemadvance force can be retarded to the point of stopping extension.

Optimal material selection is a highly significant challenge. Thedesired structure must have a rare combination of features: softness,strength, radial stiffness, low thickness, freedom from leaks,flex-crack resistance, puncture resistance, appropriate coefficient offriction, the potential for modifiable geometry as a function of length,and appropriate manufacturability and cost. Monolithic materials haveproven insufficient at providing the variety of requisitespecifications.

It can be difficult to create a system that is of adequately lowstiffness. Larger diameters create higher propulsive forces, but theyalso do not typically readily conform to the colon in a lumen-centricmanner and can be overly stiff.

Historically, several solutions have been suggested. One involvesperiodically depressurizing the system then withdrawing elements so thattheir leading edges match. This is time consuming and creates anundesirably non-continuous and geometrically interrupted procedure. Itis also very difficult to create ‘correct’ undesirable relative motionto a deflated structure that essentially is no longer a structure.Another approach involves driving the inner lumen (typically with aspecial, thicker, anti-buckle wall). Because it is driven in compressionrather than through pressure, the everting front can be inflated to alower pressure such that its pressure clamping forces are lesssignificant. This approach, augmented by the significant infusion ofliberal amounts of interluminal lubricants, should enable advance.However, it has yet to be commercialized, it is very complicated,creates an undesirably larger diameter instrument, has lubricationleakage issues, and breaks down at longer advance lengths.

Additionally, colonoscopic devices have found it notably challenging tocreate methods to appropriately navigate through torturous geometries,particularly without undue colon wall stresses and subsequent mesocolonstretch. Steering kinematics are critical and have been an ongoingchallenge—certainly for existing colonoscopes (which result in‘looping’), but also to more effective next-generation devices.

Numerous driven tubes have been proposed for colonoscopy. Some utilizetube inlaid elements driven in compression. Others utilize tubes thatare pressure driven, with their tubes being of multiple varieties,including the bellows variety, or everting types, or other storedmaterial varieties, including scrunch, fold, or spooled versions.

The systems proposed to-date have geometries that create suboptimalsteering efficacies. When a propulsion tube section's leading edge thenhas a steering section more distal, with typically a camera, lightingsource, and working channel exit at the tip, the steering is less thaneffective when going around a corner: A situation is created in whichthe tip is retroflexed and is pointing in one desired direction ofadvance, but the system's advance is in an exactly opposite direction.The driven section presumes a vector—typically an axial manner—with thesteering tip only having efficacy as it relates to its interaction withluminal walls. In a colonoscopy, this wall interaction is undesirable—itcreates unnecessary wall stress and trauma, and can be a significantcontributor to gross wall distortion, known as looping.

It would therefore be desirable to have system designs that enable morelumen-centric steering as the unit is advanced through colon curvature.Other improvements are also desired.

BRIEF SUMMARY OF THE INVENTION

A device for navigation of passageways is disclosed. The device can beutilized for biological passageways. The device can be a colonoscope fornavigating the colon. The colonoscope can be attached or integral withother elements to form a colonoscopy system. The colonoscopy system cancontinuously examine and/or treat the colon. The colonoscopy system canhave a deployment or ‘base’ system, a driven everting tube system, acontrollable tip with multiple utility elements, system controls, andcombinations thereof.

The colonoscope can be substantially round in cross section. Thecolonoscope can substantially elongate or deform along its longitudinalaxis in a multitude of manners. The colonoscope can have thin walls. Thecolonoscope can be configured to stretch. The colonoscope can beconfigured to be deployed to reach the cecum. The colonoscope can havean everting tube or otherwise pressure driven tube system.

The everting tube system can have a thin wall, flexible (e.g., but stillradially stiff) tube that can unfurl or roll back on itself for examplefrom the inside out. The everting tube can be driven forward with a pushtubes (e.g., an everting element cavity support), by driving or pushingthe wall along its central axis, or through pressurization (e.g.,pressurizing gas or fluid, such as air or water, in the everting elementcavity). As the tube is driven forward, the tube's tip (e.g., a tipdistal end and/or the everting element tip) can be “fed” with morematerial that can come from several potential location sources:internally or externally, near the tip or near the base. The system canevert continuously or sequentially.

The everting tube outer section (278) can have the highly minimized lackof motion relative to the biological luminal (e.g., colon) wall duringthe System's advancing process. If the everting tube system were to bereversed by retracting the everting tube inner section, the evertingtube can be configured to have either motion or no motion relative tothe luminal wall during withdrawal of the everting element. The evertingtube can be used in the GI tract (e.g., colon), the coronaryvasculature, the brain, and in urologic lumens.

The everting tube system can have male geometric features that createvoids (e.g., female geometries), to create one or more channels, insidethe center lumen of the tube system. The one or more channels (e.g.,working channels) can enable the passage of deployable elementstherethrough. The deployable elements to be passed can be instruments,electronics (e.g., power and signal wires), fluids (e.g., water, salinesolution, air, carbon dioxide, suction), biomatter captured from withinthe colon, and combinations thereof.

The geometries can be robust with regard to certain load applications.For example the features can be strong enough relative to pressure loadssuch that when the everting tube driving pressure is applied, thechannel can remain substantially patent. The system or sheath can beflexible enough to deconstruct or ‘open up’ and evert at the tip, suchthat the sheath can navigate the colon while providing a full-lengthworking channel. Once the sheath has everted, the sheath can haveatraumatic configurations on the outside of the wall, in proximity tothe inside surface on the colon wall.

When the tube system is reversed (e.g., when an outer everting elementis extended or when an inner everting element is retracted), the sheathcan reform to again form luminal elements, or not reform.

The sheath can have elements that interface from one side to another(e.g., such as a zipper lock seal, or other interlocking seal), or aplanar element interfacing on another planar element (e.g., creating aface seal). The sheath can have tubular geometries—with radial symmetryor not—which can be deconstructed as portions of the sheath evert at ornear the system's tip.

The sheath can have tear or break-away geometries which remain integraluntil deployment to the tip, after which they separate into disparateparts.

The sheath can stay clamped together, for example, for the face sealedsheath, and/or for example when the everting tube driving, pressureexceeds internal pressures and forces (e.g., fluid/air/solid elementpassage forces). The sheath can have indexing elements that can minimizeor prevent lateral motion or sliding, for example, to further preventthe sheath from separating. As the sheath everts at the tip, there aregeometries which interface such that the everting tube lumens connect totip geometries and their lumens. For example, a short, thin wall tubesection can extend backwards from the tip, penetrating one of thelumens. This interaction ensures the relatively continuous passage oflumen elements through to the proper tip interaction and ultimate exit.

The colonoscope can have a tip region and system. The tip can have acontrollable frontal or distal end that can have the terminus of workingchannels, lighting, and vision systems. The tip can be in a tip channelin the tube (e.g., everting element). The tip channel can be patentwhile the everting element is fully inflated. Tips, tools, fluids andother electronics can be deployed through the tool channel.

The tip can be used for tissue characterization imaging. The tip canperform an optical, non-invasive, “biopsy” on tissue. The tip can havean element to locally dispense pharmaceutical elements, for example forlocal drug delivery.

As the colonoscope advances, the tip can skew to die horizon. This cancreate disorienting, skewed images for the user. The colonoscope canhave a dedicated actuator for rotating the tip about the tip's centralaxis. The tip can feature a ‘plane’ or ‘horizon’ indexing feature. Asthe view becomes skew relative to that plane, the actuator for rotatingthe tip can rotate the tip and/or software can rotate the image.

The tip can have remote or local (i.e., in the tip) actuators. The tipactuators can include pull cables. The tip actuators can include localor remote hydraulic members that act as cylinders. When used withvalves, the hydraulic members can create flexed tip structures. The tipactuators can include one or more local motors, for example, servomotors, open-loop motors, piezo motors, ultrasonic motors, orcombinations thereof. Electric tip actuators can be powered by localbattery sources, by long, small gage wires extending to a power sourceat the base, or combinations thereof. The tip actuators can be resilientor heat memory alloys, such as Nitinol-based.

The tip can be actuated by multi-axis actuators. The tip can point orflex in a range or cone of motion, including distally, laterally,proximally, or combinations thereof. For example, the tip can retroflex.

The tip can have lighting, for example LEDs. The tip lighting can bepowered by small gage wires extending from the tip to a power source ator near the base. The tip lighting can be powered locally (e.g., by abattery).

Data signals (e.g., image electric signals) can be transmitted by smallgage wires extending from the tip to an imaging processor at or near thebase. The data signals can be transmitted by wires or wirelessly.

The colonoscope can be removed from the colon. The colonoscope can befully or partially deflated and withdrawal. An actuator (e.g., motor)can withdraw the colonoscope from the colon. The colonoscope, can bemanually withdrawn from the colon. The colonoscope can be withdrawnwhile inflated.

The colonoscopy system can have a controller. The controller can controlthe pump. The controller can execute one or more algorithms to modulatethe operating pressure of the pump. The controller can be connected topressure sensors in the colonoscopy system. The controller can beconnected to sensors that detect the length that the colonoscope hasextended. For example, these algorithms can start the operating pressureat a given value, then increase the pressure as the extended length ofthe colonoscope increases. The algorithms can reduce the pressure duringretraction or withdrawal of the colonoscope. The algorithms can increasesystem reliability and efficacy, and reduce the operators cognitiveload.

The colonoscope can be withdrawn by applying a tensile load to the outermember, for example to the everting element outer section. Thecolonoscope can be withdrawn by pulling on the everting element-outerand/or inner sections, for example the central lumen or umibical(s). Thecolonoscope and its umbilical(s) can be released and/or withdrawn into asubstantially linear orientation, or into a substantially rotary(‘spooled’) orientation. During withdrawal, the colonoscope's evertingtube component can be split after the colonoscope passes apressurization spool, such that a portion of the tube is on a firstspool, and a portion is on a second spool. The spools can be actuator,motor, or manually driven. The colonoscope can be withdrawn by actuatingmechanisms that retract the tube, sliding, folding, bunching orscrunching the tube onto a guide tube. The folded, scrunched or bunchedlength of the tube can be compressed compared to the unfolded, unbunchedor unscrunched length of the tube. One or more high friction wheelsand/or levers can retract the tube, for example by applying a tensileforce to the tube.

The everting tube system can be driven with solids (e.g., granular orbeads), gels, liquids, gasses, or combinations thereof. The fluid canhave a low viscosity. The fluid can be piston-driven or otherwise drivenby a solid displacement pump.

The sheath and/or everting element can be made from PTFE, a plastic,LDPE, including multiple ‘low stiction’ blends, Nylon (including use ofNylon-on-Nylon), or of composite construction, including with reinforcedmembers. Lubricants can be applied to the sheath and/or evertingelement, for example to reduce drag/friction. The lubricants can includefluids such as water, glyercine (glycerol), other glycol-based fluids,vegetable oils, silicones, graphites (e.g., with superlubricityproperties), PAO (poly-alpha-olefin), dispersions including of lubrousmaterials such as Boron Nitride (BN), colloidal dispersions of PTFE.Molybdenum disulfide coatings and additives in lubricants can be appliedto the sheath and/or everting element. Dry film coatings can be appliedto the sheath and/or everting element. Synthetic fluids and mineral(petroleum-based) fluids can be applied to the sheath and/or evertingelement. The fluids can be biocompatible and non-toxic, such asskin-contact friendly.

The sheath and/or everting element can have one or more geometricelements that can have varying cross sections as a function of length.For example, the sheath and/or everting element can be tapered orlocally bulbous.

The sheath and/or everting element can have material stowed along thelength of the sheath and/or everting element, at or near the base, or ator near the tip. The stowed material can be released in a manner tosubstantially create 1:1 eversion front to tip motion. The material canbe stowed in various forms, including oriented substantially parallel tothe umbilical's central axis, or substantially perpendicular. Thematerial can be stowed in a random manner, or in a pre-determinedmanner. The stowed material can be orderly stowed as multiple folds,parallel to the umbilical's central axis, that deploy in an intentionalsequential manner. The stowed material can be in otherwise compactedform.

The tube can have radially internal and/or external channels forcarrying a tool. For example, the channels can be formed by one or morecoils or clips.

The tube of the everting system can be disposable and delivered in amodified ‘spool’ or ‘cassette’. The tube can be loaded, snapped in, orotherwise be readily and quickly attached to the base structure. Oncethe procedure is complete, the utilized spool or cassette can beremoved.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is not the invention and illustrates a colon.

FIG. 2 is not the invention and illustrates a variation of a perspectiveview of a transverse cross-section of a colonoscope.

FIG. 3 is a perspective view of a variation of the end of thecolonoscope.

FIG. 4 is cross-section A-A of a variation of the colonoscope of FIG. 3.

FIG. 5 is a perspective view of a variation of the end of thecolonoscope shown without the tip.

FIGS. 6, 8 and 9 illustrate cross-section C-C of variations of thecolonoscope of FIG. 5.

FIG. 7 illustrates a variation of the colonoscope in which the centrallumen opens and tearably everts at its leading edge.

FIGS. 10 a through 10 i illustrate cross-section C-C of variations ofthe reinforcement and the surrounding everting element layer.

FIG. 10 j illustrates a perspective view of a section of a variation ofthe reinforcement and the surrounding everting element layer.

FIG. 11 is a perspective view of a variation of the end of thecolonoscope.

FIG. 12 is cross-section D-D of a variation of the colonoscope of FIG.11.

FIG. 13 is a perspective view of a variation of the end of thecolonoscope.

FIGS. 14 a and 14 b are cross-section E-E of variations of thecolonoscope of FIG. 13.

FIG. 15 illustrates an embodiment of a coil configured to allow sideexit of a tool within the coil.

FIG. 16 is a perspective view of a variation of the end of thecolonoscope.

FIGS. 17 a through 17 e illustrate variations of the clips.

FIG. 18 is a perspective view of a variation of the end of thecolonoscope.

FIGS. 19 through 22 illustrate cross-section G-G of variations of thecolonoscope of FIG. 18.

FIGS. 23 a, 23 b, 24 a and 24 b illustrate cross-section C-C ofvariations of FIG. 5.

FIGS. 25 and 26 illustrate cross-section B-B of variations of thecolonoscope of FIG. 3.

FIG. 27 illustrates cross-section B-B of a variation of a method ofeverting a variation of the colonoscope of FIG. 3.

FIG. 28 illustrates cross-section B-B of a variation of the colonoscopeof FIG. 3.

FIG. 29 illustrates cross-section B-B of a variation of a method ofeverting a variation of the colonoscope of FIG. 28.

FIG. 30 illustrates cross-section B-B of a variation of the colonoscopeof FIG. 3.

FIGS. 31 and 32 illustrate variations of the colonoscope.

FIG. 33 illustrates a variation of the colonoscope, for example that canhave a two-piece structure created with an inner film tube and an outercloth tube.

FIGS. 34 and 35 illustrate a perspective view of a circular or spooledversion of the deployment system.

FIGS. 36 a and 36 b illustrate a variation of a cross-section of thedeployment system and a cross-section A-A of the system therein,respectively.

FIG. 37 illustrates a top perspective view of a cassette with thecassette lid removed.

FIGS. 38 and 39 illustrate variations of methods for everting anddeverting the colonoscope.

FIGS. 40 and 41 illustrate a variation for retracting the colonoscope inwhich the outer member is put in tension so as to not buckle. As thematerial is withdrawn it is split and then drawn onto spools. As theouter member is retracted, the inner umbilical(s) can be retracted in amanner, for example, to not put substantial compressive loads on thesheath.

FIG. 42 is a side view of a variation of a system for driving theeverting systems in which the everting tube is stowed in a small volume,and in which the everting tube's pulled umbilical is stored in asubstantially not-spooled and not-pressurized manner.

FIG. 43 is a perspective view of the system for driving the evertingsystem of FIG. 42.

FIG. 44 is a close-up and partial cut-away view of the system fordriving the everting system of FIG. 42.

FIG. 45 illustrates a cross-section of a variation of the colonoscopeloaded into a substantially rotary cassette.

FIG. 46 a through 46 f illustrates a variation of cross-section Z-Z ofFIG. 45.

FIG. 47 a illustrates a perspective view of a variation of thecolonoscope with two tools deploying therethrough.

FIG. 47 b illustrates a variation of cross-section Y-Y of FIG. 91 a.

FIG. 47 c illustrates a variation of cross-section X-X of FIG. 91 c.

FIG. 48 a illustrates a variation of a colonoscope system in a firstconfiguration.

FIG. 48 b illustrates a variation of a colonoscope system of FIG. 48 ain a second configuration.

FIG. 49 is a schematic view of a variation of the base and a fluidsystem.

FIG. 50 a illustrates a variation of the system base station capitalequipment.

FIG. 50 b illustrates a variation of a method for using the colonoscope,in which a piston or otherwise extensible displacement member ismanipulated to control load volume to exert a corresponding pressureonto an everting tube.

FIGS. 51 through 57 illustrate a variation of a method for using thecolonoscope.

DETAILED DESCRIPTION

FIGS. 3 and 4 illustrate an elongated element for navigation ofbiological passageways, such as an endoscope for navigating theesophagus and stomach or a colonoscope 44 for navigating the colon 10.The colonoscope can be used to treat and/or diagnose polyps, lesions,tumors, ulcers, trauma, colitis, infarction, displasia, diverticulosis,diverticulitis, impactation, Crohn's disease, or combinations thereof.The colonoscope can be configured to translate and/or rotate along thecolon by everting.

The colonoscope can have a biological navigation device such as aneverting element 46 or tube. The everting element can be a tubeconfigured to evert when the everting element is deployed.

The colonoscope or everting element can have a sheath. The sheath can bean elastic, non-elastic, distensible, expandable sheath and/or aseparatable sheath 54. The sheath can cover most or substantially theentire everting element. The separatable sheath can have a higher,lower, or equally frictional surface than the surface of the evertingelement.

The colonoscope can have a tool emergence tip. The tip can be locatedradially inside the everting element and/or the separatable sheath. Thetip can serve as the effective exit locale of one or more diagnosisand/or treatment elements, such as any or all of the conduits shown inthe colonoscope in FIG. 2.

The everting element can have an everting element inner section 50, aneverting front 52 and an everting element outer section 48. The evertingelement inner section, everting front and everting element outer sectioncan be integral with each other. The everting element inner section canbe in the radial center of the everting element. The everting elementinner section can translate distally (i.e., toward or beyond theeverting front) as the everting element is deployed. The everting frontcan rotate or roll in a radial outward direction. The already evertedportion of the everting tube can be substantially motionless relative tolocal anatomy as the leading edge's everting system elements aredeploying. The everting element outer section can have material (i.e.,rolling over from the everting element inner section via the evertingfront) added to the length of the everting element outer section whenthe everting element is deploying. When the everting element isretracted, the everting element's outer elements can be imparted with atensile load. Alternatively, the umbilical can receive the system'stensile load to enable retraction.

A tool channel (shown in FIGS. 5 and 6) can be defined by the radialcenter of the everting element.

The everting element can define an everting element cavity 82. Theeverting element cavity can be pressurized, for example when theeverting element is deploying or deployed. The everting element cavitycan be sealed fluid-tight. The everting element cavity can be filledwith saline solution, water, air, carbon-dioxide, oxygen, or otherelements and combinations thereof.

The separatable sheath can have a separatable sheath inner section 55and a separatable sheath outer section 57. The separatable sheath canhave a separatable sheath first inner section 66 and a separatablesheath second inner section 68. The separatable sheath can have aseparatable sheath first outer section 56 and a separatable sheathsecond outer section 58. The separatable sheath inner section 55 can bebetween the everting element inner section 50 and the tool channel 72.The separatable sheath outer section 57 can be radially outside of theeverting element outer section 48.

The separatable sheath can have one; two or more seams. The seams can beeven distributed angularly around the longitudinal axis. For example,the separatable sheath can have two seams on opposite sides of theseparatable sheath. Along the separatable sheath inner section, the seamcan be a closed seam 62. Along the everting front, the seam can expandand open. Along the separatable sheath outer section, the seam can be anopen seam 60. The seam can be configured to be recloseable or notrecloseable. The closed seam can be fluid-tight, such as water-tight orair-tight.

The tip can have a tip body 70. The tip can have a distal end 64 and atip proximal end and can be the distal terminus of an umbilical(s) whoseother terminus is a base structure. The umbilical(s) can have wires,cables, conduits, and combinations thereof that can extend proximallyfrom the tip and/or tip body and/or tip distal end.

The tip can be comprised of multiple elements that move slidablyrelative to each other. This can serve to enable local motion withouthaving to manipulate a larger macro structure.

FIGS. 5 and 6 illustrate the longitudinal axis 76 of the colonoscope.The tool channel 72 of the colonoscope can be a real patent space (or avirtual space. A virtual space can be a potential space between one ormore flexible surfaces that can be opened when an element orpressurization is placed into the virtual space). The tool channel canbe substantially round, such as cylindrical or oval. The tool channelcan be configured to fit the tip body 70. The tool channel can be openat the distal and/or proximal ends of the everting element.

The colonoscope (shown with the tip missing for illustrative purposes)can have one, two, three, or more reinforcements 74. The reinforcementscan be integral with and/or attached to the everting element. Thereinforcements can be substantially evenly angularly distributed withrespect to the longitudinal axis. The reinforcements can be ribbons,filaments, tubes, one or more meshes, or combinations thereof. Thereinforcements in the everting element outer section and evertingelement inner section can be substantially parallel with thelongitudinal axis.

FIG. 7 illustrates a variation of the separatable (e.g., splittable)sheath. The separatable sheath (e.g., a secondary tube), for examplemade from PTFE, can be bonded or otherwise attached to the inside of theeverting tube. The separatable sheath can have linear tear propagationproperties. The linear tear propagation effect can be created in othermaterials through multiple manufacturing methods, including necked-downregions and scoring. As the separatable sheath inside the everting tubereaches the eversion front, the separatable sheath can split and/or tearto either side. The separatable sheath can be an end-to-end conduit fortool or umbilical elements, for example with one or more appropriateend-termination geometries for the tip. The separatable sheath can besubstantially smaller than the everting element. The separatable sheathouter sections can be unattached to the everting element outer section.

The tool channel can be a virtual space. The tool channel can expand,for example, when filled with an element (e.g., the tip body). The toolchannel can be substantially closed, for example, when not filled withan element.

FIG. 8 illustrates that the everting element can have one or more innerlayers and one or more outer layers. The everting element can have aneverting element inner section inner layer 53 and an everting elementinner section outer layer 55. The everting element 46 can have aneverting element outer section inner layer 51 and an everting elementouter section outer layer 49.

The reinforcements can be between the everting element inner layer andthe everting element outer layer. The reinforcements can be attached toand/or integral with the everting element inner layer and/or theeverting element outer layer.

The reinforcements can be solid and/or hollow. The reinforcements haveintra-reinforcement channels 78. Extra-reinforcement channels 80 can bedefined between the reinforcements, the everting element inner layer andthe everting, element outer layer. The intra-reinforcement channelsand/or extra-reinforcement channels can be real and/or virtual spaces.The reinforcements can be added to the tube surface, or created integralwith the tube surface.

The intra-reinforcement channels and/or extra-reinforcement channels canbe filled with fluid (e.g., pressurized or non-pressurized air, water,saline solution, carbon dioxide, or combinations thereof), and/orsensing, and/or treating equipment, such as heating wires, thermalsensing wires, light-emitting wires, or combinations thereof.

FIG. 9 illustrates that the everting element can have an angularlyasymmetric configuration with respect to the longitudinal axis, forexample the everting element can have a substantially ovalcross-section. The reinforcements can be angularly asymmetricallylocated with respect to the longitudinal axis. For example, thereinforcements can all be located on half (angularly with respect to thelongitudinal axis) of the everting element.

FIG. 10 a illustrates that the reinforcements can have a substantiallyround cross-section, such as a circular or oval cross-section. Thereinforcements can have male standoff geometries. The male standoffgeometries can abut the everting tube to form female channels, forexample in which tools (e.g., elongated elements) can be received. Asthe tube everts, these geometries transition from the inner surface ofthe tube to the outer surface of the tube. When the tube is reversed,they can reform to continue to create end-to-end lumen(s). FIG. 10 billustrates that the reinforcement can have a reinforcement slot 118.The reinforcement slot can be located away from the everting elementlayer 84. The reinforcement slot 86 can have a length of all or part ofthe reinforcement. A single reinforcement can have one or morereinforcement slots.

FIG. 10 c illustrates that the reinforcement can have a substantiallysquare or rectangular cross-section. FIG. 10 d illustrates that thereinforcement slot can be in the everting element layer. Thereinforcement slot can be the width of the reinforcement. Thereinforcement slot can be the width of the union of the reinforcementand the everting element layer.

FIG. 10 c illustrates that the reinforcement can have anintra-reinforcement width 88. An extra-reinforcement width 89 can bebetween adjacent reinforcements. The intra-reinforcement width can begreater than, equal to, or less than the extra-reinforcement width. Theintra-reinforcement widths can be constant or vary for all thereinforcements of a single everting element. The extra-reinforcementwidth can be constant or vary between all the reinforcements of a singleeverting element.

FIG. 10 f illustrates that the reinforcements can be vane reinforcements90. The vane reinforcements can extend perpendicular or at a non-rightangle to the everting element layer. The vane reinforcements can beabout as thick as, thinner than, or thicker than the everting elementlayer.

FIG. 10 g illustrates that the vane reinforcements can have asubstantive thickness, significantly thicker than the everting elementlayer. Two or more reinforcements can be attached or integral with eachother separate from attachment or integration via the everting elementlayer. For example, a single reinforcement can have two, three, four ormore vanes.

FIG. 10 h illustrates that the reinforcement can have a taperedconfiguration as the reinforcement extends away from the evertingelement layer. The reinforcements can have flanges 92 at the ends of thereinforcements away from the everting element layer. FIG. 10 iillustrates that the reinforcement can have a spine 94. The spine canhave a substantive thickness. The spine can be substantially parallelwith the everting element layer. The spine can be integral with and/orattached to the remainder of the reinforcement (e.g., vanes).

FIG. 10 j illustrates that the reinforcement can have one or morehinges, such as a first hinge 96 and a second hinge 98. The hinges canbe evenly or unevenly spaced or distributed along the length of thereinforcement. The hinges can be cut, removed, or otherwise missingmaterial from the reinforcements. The hinges can be cut, removed, orotherwise missing material transverse to the longitudinal axis. Thehinges can serve to maintain an end-to-end lumen during pressurization,but also to enable lower-force eversion.

FIGS. 10 a-10 j illustrate the reinforcements attached to and/orintegral with a single everting element layer, however thereinforcements can also be attached to and/or integral with multipleeverting element layers.

FIGS. 11 and 12 illustrate that the separatable sheath can have a singleseam.

FIGS. 13 and 14 a illustrate that the separatable sheath can have one ormore separate or integral tensile elements across the seam, for example,for providing tension. The tensile elements can form external carriersor conduits. The tensile elements can be placed through the separatablesheath and/or the everting element regardless of whether the tensileelement bridges a seam or not. The tensile elements can be in tension ornot in tension. The tensile elements can be expandable attachers 102.The tensile elements can be resilient or deformable. The tensileelements can be coils 100. The coils can be filaments and/or springs.The coils can expand across the open seam. The coils can contract acrossthe closed seam.

The coils can be attached to the sheath and/or the everting element. Thecoils can be driven (e.g., sewn or punched) through the separatablesheath first section and the separatable sheath second section, and/orthrough the everting element first section and the everting elementsecond section. The coils can apply tension across the open seam or thecoils can be relaxed across the open seam. The coils can apply tensionacross the closed seam or the coils can be relaxed across the closedseam. The coils can serve to provide a tube or conduit along the lengthof the system, such that an umbilical(s) could be slidably manipulatedalong its axis. A single coil can extend the length of the evertingelement. Once the tube is everted at its tip, this conduit then goesinside of the everting tube.

FIG. 14 b illustrates that the coils can be configured to createintra-coil channels 104 and/or tool subchannels 104 within the coils.Tools can be deployed in the inner or outer intra-coil channels. Thecolonoscope can have, or be absent of any, sheath.

FIG. 15 illustrates that the coils can have side ports 106. The sideports can be used to introduce or remove a tool, umbilical, or otherdevice in the intra-coil channel (e.g., tool subchannel).

FIG. 16 illustrates that the tensile elements can be one or more clips108. The clips can be parallel or non-parallel with respect to eachother. The clips can be perpendicular, parallel, or non-perpendicularand non-parallel with respect to the longitudinal axis of the seamand/or the longitudinal axis of the colonoscope. The clips can beresilient and/or deformable. The clips can have a relaxed configurationand a flexed configuration. The dimensions, materials, and resiliency ofthe clips can vary between different clips. The clips can be configuredto form intra-clip channels and/or tool subchannels 104 within theclips, similar to those shown for the coils in FIG. 14 b. These clipsprovide elements of an external ‘track’ upon which an umbilical(s) couldslide.

FIG. 17 a illustrates that the clip can have a “c” configuration. Theclip can be curved along the entire length of the clip. FIG. 17 billustrates that the clip can have an extended clip back 110. The clipback can have a straight length. FIG. 17 c illustrates that a clip firstarm 112 can cross a clip second arm 114. The clip first arm can be incontact with the clip second arm when the clip is in a relaxed and/orflexed configuration. The clip first arm and/or clip send arm can havestraight lengths. These coils can have ‘split’ or ‘c’ channel geometriesto enable entry at the eversion front, particularly when used inconjuction with an eversion front opening wedge.

FIG. 17 d illustrates that the clip can have a substantially squareconfiguration. The clip can be configured with sharp angles, such asright angles. The clip can have all straight lengths. FIG. 17 eillustrates that the clip can have multiple right angles, all straightlengths, and an extended clip back.

FIGS. 18 through 22 illustrate that the seam can have an interlockingseal, such is a sealable slide fastener or zip-fastener, such as azipper. The interlocking seal can have or be without a separate slidingtab. The interlocking seal can have one or more resilient stripsconfigured to fit into one or more respective grooves in the face of agasket or o-ring.

FIG. 19 illustrates that the interlocking seal of the seam can beconfigured to extend radially inward, with respect to the longitudinalaxis of the colonoscope, from the separatable sheath inner section andradially outward, with respect to the longitudinal axis of thecolonoscope, from the separatable sheath outer section. FIG. 19illustrates that the interlocking seal of the seam can be configuredsubstantially in a constant radius plane with respect to thelongitudinal axis of the colonoscope. The interlocking seal of the seamcan be substantially unobtrusive of the tool channel or radially outsideof the everting element.

FIGS. 21 and 22 illustrate that the interlocking seal of the seam can beconfigured to extend radially outward, with respect to the longitudinalaxis of the colonoscope, from the separatable sheath inner section. Theinterlocking seal of the seam can be configured to extend radiallyinward, with respect to the longitudinal axis of the colonoscope, fromthe separatable sheath outer section, and/or be configured substantiallyin a constant radius plane with respect to the longitudinal axis of thecolonoscope.

FIG. 21 illustrates that the separatable sheath inner sections can beconfigured to lie substantially flush against the everting element innersection, for example except for directly adjacent to and including theclosed seam. The separatable sheath inner section can extend from theseal at an acute or right angle.

FIG. 22 illustrates that the separatable sheath inner section can beconfigured to partially distance itself away from the everting elementinner section, for example forming a seam channel 116. The separatablesheath inner section can extend from the seal at an obtuse or rightangle.

FIG. 23 a illustrates that the colonoscope can have reinforcementsextending, radially with respect to the longitudinal axis of theeverting element, from the separatable sheath. The reinforcements caninterdigitate with other reinforcements. The reinforcements can extenddirectly from the everting element, for example if the colonoscope hasno separatable sheath. The separatable sheath can be sufficientlyelastic to expand. The separatable sheath can have no seam. Thereinforcements can be evenly or unevenly distributed around the evertingelement, angularly with respect to the longitudinal axis of the evertingelement.

FIG. 23 b illustrates that the reinforcements can haveintra-reinforcement channels or tool subchannels. The reinforcements canhave reinforcement slots. The colonoscope can have a sheath or be absentof a sheath. The reinforcements can have substantially square orrectangular cross-sections.

FIG. 24 a illustrates that the colonoscope can have reinforcements thatdo no, not interdigitate. The reinforcements can be evenly or unevenlydistributed around one half of the everting element, angularly withrespect to the longitudinal axis of the everting element.

FIG. 24 b illustrates that the reinforcements can haveintra-reinforcement channels or tool subchannels. The reinforcements canhave reinforcement slots. The colonoscope can have a sheath or be absentof a sheath. The reinforcements can have substantially round or ovalcross-sections.

FIG. 25 illustrates that the everting front 122 can abut the tip, forexample at the tip head. The everting front can be in contact with ornot in contact with the tip, for example at the tip head.

FIG. 26 illustrates that the everting element can have a reinforcingcoil, shown as a distal reinforcing coil 174. The distal reinforcingcoil can increase the axial and/or radial rigidity of the evertingelement. The reinforcing coil can encircle the everting element innersection. The reinforcing coil can be pulled onto the inner radial sideof the everting element outer section. The reinforcing coil can be inthe everting element cavity. The reinforcing coil can be slidablyattached to the everting element. The reinforcing coil cab be fixedlyattached, for example by sewing, interweaving, glue, staples, or acombination thereof, to the everting element. The reinforcing coil canextend a portion of, or the entire length of, the everting element.

FIG. 27 illustrates that the everting element inner section cantranslate distally, as shown by arrows 128. The translation of theeverting element inner section can be from, for example, pressure in theeverting element cavity in addition to slack provided for the evertingelement inner section. The everting element outer section can remainsubstantially translation-less. When a point on the everting elementinner section translates to the everting front, that point can rotateradially outward and stop translating when that point becomes static onthe everting element outer section. As the everting element expandsdistally, the tip can translate, as shown by arrow 126, distally.

A force can also be separately applied to the tip body during deployment(and withdrawal) of the everting element. The tip body can be maintainedat, for example, a 1:1 translation ratio with the everting front. Thetip body can slide within the separatable sheath. For example the tipbody can slide against a low friction surface contact with theseparatable sheath inner sections.

FIG. 28 illustrates that the colonoscope can have a gasket 130 betweenthe everting element and the tip body. The gasket can be on either sideof the separatable sheath inner sections. The gasket can be a lowfriction interface between the tip body and the everting element. Thegasket can fluidly seal between the everting element and the tip body.

FIG. 29 illustrates that the tip can be translated distally (andproximally) with respect to the everting element. A distal force can beapplied to the tip relative to the everting element, resulting in distaltranslation, as shown by arrow, of the tip body and tip head. The gasketcan roll or slide between the everting element and the tip body when thetip body is translated with respect to the everting element.

FIG. 30 illustrates that the everting element cavity can have aneverting element cavity support 83. The everting element cavity supportcan be a rigid or resiliently or deformably flexible tube that can fitin the everting element cavity 82. Distal translational forces can betransmitted through the everting element cavity-support, for example, todrive the everting element. The everting element cavity support can havetreatment and/or diagnostic instruments. For example, the evertingelement and separatable sheath can be transparent to specific RFwavelengths emitted by diagnostic or therapeutic instruments in theeverting element cavity support.

FIGS. 31 and 32 illustrate that additional, pre-loaded length of theeverting element inner section can be stowed or held; along the lengthof the everting element. The everting element inner section can stowedalong the length of the tip body and/or tool channel. As pressure isincreased in the everting element cavity, for example, the stowedmaterial can extend its length, thereby driving forward the tip and itstowed umbilical(s).

FIG. 33 illustrates that the everting element can be covered and/or madefrom a fabric or other mesh. The everting element can have a fabric,mesh, or filament reinforcement. The fabric can be a cloth sewntogether, for example with a stitch 132. The fabric can be or have nylonfilm liner, such as rip-stop nylon parachute ‘sportchute’ cloth.

Alternately, it can be comprised of a substantially one-piece compositestructure.

The everting element can be made from one or more layers of film and/orfabric (e.g., cloth). The everting element can be air-tight. Afiber-based element can provide tensile carry loads, and the otherelements can provide a unifying and sealing utility. Films or othertypes of sealant utility can attained from multiple material disclosedherein including LDPE, PET, and/or nylon. The everting element can beconfigured to be smooth and non-irritating and/or to provide abrasionagainst the colon wall.

Fibers and cloths in the everting element can include those made fromKevlar, spectra, nylon, Dyneema, or combinations thereof. The fibers canbe coated with polyesters, or a range of other sealants, such as DWRs(durable water repellants). The fiber-based elements can be deployedeither as laminated unidirectional material, or woven or knitted. Thelayers of the everting element can be sewn together, bonded by wetadhesives or film adhesives.

FIG. 34 illustrates a variation of the deployment system 152. Thedeployment system can be attached to the colonoscope to form acolonoscope system. The deployment system can define a sealabledeployment system cavity 144. The deployment system cavity 144 can bebounded by a seal 134. The deployment system cavity can be in adeployment system base. The deployment system can form a sealed elementin multiple form factors, for example a circular spool based system, alinear system, a purely locally pressurized system, hand-held system,scope-mounted system, table-based system, table-mount-based system,patient-based system, or combinations thereof.

The deployment system cavity can be in communication with an inlet port150 or base pressure port and an outlet port or exit port 148. Theoutlet port can have an exit fitting 146. The exit fitting can beconfigured to attach to a colonoscope, and/or to deploy a colonoscopetherethrough. The inlet port can be configured to be attached to a fluidand or gas source, and/or a pump (not shown). The pump can deliver acontrollably variable or constant pressurized media. The deploymentsystem cavity can be in fluid communication with more than one inletport. For example, additional inlet ports can be used to controllablyintroduce other fluids (e.g., lubricant) or solids (e.g., additionallength of colonoscope).

FIG. 35 illustrates that the deployment system base 154 can be attachedto a deployment system lid, for example with a fluid-tight seal. Thecassette can have a cassette spool 136. The drive spool 138 can beattached to the drive shaft 140 on the outside of the deployment systemcavity 144. The deployment system lid 160 can be fixed to a motor mount156 adjacent to the drive spool. Alternatively, the spool can be remotefrom the lid (for example, affixed to the bottom of the base andconnected with a radial seal) to allow for the easy transfer ofcartridges without having to disturb the drive motor configuration. Themotor mount can be attached to a deployment motor (not, shown), that canattach to the drive spool 158. The deployment motor can rotate the driveshaft, causing deployment of the colonoscope.

FIGS. 36 a and 36 b illustrate that the deployment system base 162 canhave a toroidal or ring pressure chamber 144. The toroidal or ringpressure chamber can minimize pressure area while allowing the use oflarge-diameter spools or cartridges. Large-diameter cartridges or spoolscan reduce the capstan drag that develops-before the system has left thedeployment system.

The deployment system cavity can have a drive shaft onto which a motordrive can be attached. The drive shaft can be attached to or integralwith a drive spool.

The deployment system cavity can have a cassette spool. The cassettespool can be loaded with a length of the colonoscope (not shown forillustrative purposes), for example fed into the everting tube innersection 276. The cassette spool can be removably attached to thedeployment system cavity, for example, removably attached to the driveshaft. The motor drive cog can be configured to rotate the spooledcolonoscope in the cassette spool, and/or to otherwise deploy thecolonoscope length in the cassette spool. The motor drive cog can be inthe cassette spool.

FIG. 37 illustrates that the cassette 164 can be an easy load cassettesystem. The cassette can readily be loaded into place, then connectedthrough the utilization of an multi-element electrical fitting, throughchannel connections, and steering controls. The cassette can have acassette drive shaft port 166. The cassette can have a cassette lid 168.The cassette can have a cassette base 178. The cassette can have a feedchannel 176. For example, the everting element inner section can bepushed or drawn through the feed channel and out a cassette exit port180.

The everting element inner section can be held in and delivered from aneverting element holder 174. The separatable sheath can be held in anddelivered from a separatable sheath holder 172. The holders can haveclosed canisters or drums. The holders can have one or more circular orconical spools or reels, or longitudinal elements, for example, forholding the everting element and/or separatable sheath. The evertingelement inner section and/or the separatable sheath inner sections 170(shown coaxially at their terminal ends for illustrative purposes) canbe deployed from separate holders (as shown) and be coaxially attachedto each other after the everting element and separatable sheath exit therespective holders, for example by a joining mechanism in the cassette.The everting element inner section and the separatable sheath innersections can be pre-attached to each other and, for example, deployedfrom a single holder.

FIG. 38 illustrates that one or more rotational drivers, such as gears,levers, or wheels, can rotate to apply a distal force to drive theeverting element inner section. The rotational drivers can be configuredto rotate in only one direction, for example, the rotational drivers canbe ratcheted. The rotational drivers can be in direct contact with theeverting element inner section. The everting element inner section canhave a high-friction interface with the rotational drivers. Therotational drivers can be padded. The rotational drivers can squeeze theeverting element.

As described similarly elsewhere herein, FIG. 39 illustrates that thecolonoscope system can have a fluid pressure 186 applied to thepressurizer 182. The fluid pressure can cause the everting element innersection to translate distally.

FIG. 40 illustrates that colonoscope system can have one or morerotational drivers 184 configured to reverse the everting element outersection back towards the deployment system. The rotational drivers canapply a tensile force to the everting element outer sections. Therotational drivers can be activated to withdraw the colonoscope from adeployed configuration. The withdrawn everting element outer section canbunch, scrunch, or fold between the rotational driver and the deploymentsystem.

FIG. 41 illustrates that the everting element outer section can spoolonto the one or more rotational driver. The everting element can be cutalong two lines about 180° apart from each other. The everting elementcan be split or cut by one or more bladed gaskets 188 or a blade withouta gasket. The gasket can seal the everting element cavity. The bladescan be located adjacent to the rotational drivers. The blades can beconfigured to cut the everting element outer sections.

FIGS. 42 through 44 illustrate that an alternative system formembodiment. In this embodiment the everting tube is pressurized and theoverall pressurized volume is much smaller volume than previouslydepicted, and the system is non-pressurized as it goes through thedepicted “U” shape, with the opposing legs 192 of the “U” varying withthe tip's corresponding insertion or advancement depth. This form factorcan reduce the need for capital equipment, make the procedure moremanual, and significant reduces the capstan wraps of the system beforeanal entry (as compared to spooled systems). An alternative version ofthis concept can be not ‘U’ orientated, but rather a layout thatutilizes other components mentioned, including the shaft seal, thecolonoscope shaft, and the base controls, in a substantially linearmanner. This can be used in conjunction with an existing, commerciallyavailable colonoscope, or with a custom-built low-stiffness, low-mass,small-diameter, small-drag colonoscope. The minimum storage radius 190can be more than about 8 cm (3 in.), more narrowly more than about 15 cm(6 in.), more narrowly more than about 23 cm (9 in.), for example about30 cm (12 in.). The everting element inner section can have one, two ormore substantially straight lengths. The everting element inner sectioncan make one, two, or more about 180° turns before exiting the outletport.

The system can have a connection to a pressure reservoir that isconnected to the pressurization channel 200. That reservoir can be localor remote and then connected through a tube umbilical.

The pressurization channel 200 can be in communication with the evertingelement cavity. The pressurization channel can be in fluid communicationwith the pump. The pump can be within the deployment system (as shown),or separate from the deployment system. For example, the pressurizationchannel can be placed in fluid communication with a pump central to thebuilding (e.g., connected to a wall outlet for a central pressure systemdriven by a compressor elsewhere in a hospital or other medicalfacility).

The deployment system can have a control interface 194, such as one ormore, overlapping (as shown) or adjacent knobs, buttons, switches,levers, toggles, or combinations thereof. The control interfaces can beconfigured to automatically and/or manually control the length of theeverting element inner section extending from the deployment system, theinflation pressure of the everting element cavity, the length of the tipextending from the deployment system, control or individual diagnosticand/or therapeutic elements within the tip, including the delivery of aflushing (e.g., saline) and/or anesthetic fluid through the tip. If thetip actuation is controlled by local actuators, those can be controlledby various ‘swappable’ interfaces. For example, one clinician mightprefer the standard colonoscope knob interface, whereas another mightprefer to steer with a joystick. These interfaces could be changed asper the user's preference, with each interface serving to appropriatelymanipulate the said actuators. The deployment system can have adeployment system auxiliary channel 198. An everting element connector202 can slidably receive the everting element.

FIG. 45 illustrates that the everting element inner section can bestored on a circular, oval, or conical cassette spool that has varyingstorage radius. The loops or coils of the spool can be “stacked” along astacking axis 204.

FIG. 46 a illustrates that the transverse cross-section of the channelfor the everting element in the cassette spool can be square. Thecross-section of the channel for the everting element in the cassettespool can be circular, oval, rectangular, pentagonal, hexagonal orcombinations thereof. The transverse cross-section for the evertingelement inner section (and/or the everting element outer section, notshown) can be square, circular, oval, rectangular, pentagonal,hexagonal, or combinations thereof. The transverse cross-section for theseparatable sheath can be square, circular, oval, rectangular,pentagonal, hexagonal, or combinations thereof. The transversecross-section for the tip body can be square, circular, oval,rectangular, pentagonal, hexagonal, or combinations thereof.

FIG. 46 a illustrates that the everting element inner section,separatable sheath inner section and tip body can have square orrectangular transverse cross-sections. FIG. 46 b illustrates that theeverting element inner section call have a square transversecross-section and the separatable sheath inner section and tip body canhave circular transverse cross-sections. FIG. 46 c illustrates that theeverting element inner section can have a circular transversecross-section and the separatable sheath inner section and tip body canhave square transverse cross-sections. FIG. 46 d illustrates that theeverting element inner section and the separatable sheath inner sectioncan have square transverse cross-sections and the tip body can have acircular transverse cross-section. FIG. 46 e illustrates that theeverting element inner section and the tip body can have circulartransverse cross-sections and the separatable sheath inner section canhave a circular transverse cross-section. FIG. 46 f illustrates that thecassette spool, everting element inner section, separatable sheath innersection, and tip body can have transverse circular cross-sections.

FIGS. 47 a, 47 b and 47 c illustrate that the tools 206 and 208 can bedeployed through the reinforcements and exit through the reinforcementslots 210. The reinforcements can flex around the tools, opening thereinforcement slot wider for the tools to exit through.

FIGS. 48 a and 48 b illustrate a variation of the colonoscopy system 224and a method of using the same. The deployment system of the colonoscopysystem can have the umbilical 212, extending away from the outlet portand making zero, one or more about 180° turns, for example around apulley. The pulley 216 can be on a pulley cart 218 slidably attached tothe remainder of the deployment system. The pulley cart can be attachedto a cart cable 222. The umbilical can have a linearly extending portion214.

FIG. 48 b illustrates that the pulley cart can be translated (e.g.,driven by the cart cable), as shown by arrow, toward the outlet port.The umbilical can then be slackened and able to extend, as shown byarrow, out of the outlet port. For example, the pulley cart can betranslated as shown, as the everting element is extended (e.g.,inflated).

The umbilical can be attached at a first end to the everting element.The umbilical can be attached at a second end to controls, sensing andactuating mechanisms 220.

FIG. 49 illustrates that the base can have an elongated element feeder238. The elongated element feeder or linearized system can have alinearizing extender that can travel back and forth to linearly controlumbilical extension. The linear travel of the elongated element feedercan be controlled by a motor 230 that can turn a lead screw 226 and/ordrive shaft 228 connected to the elongated element feeder. Before beingdeployed, the umbilical can be substantially straight in a pressurechamber, for example to reduce capstan drag in the elongated element (ascompared to a spooled configuration). As the elongated element feeder ismoved linearly, it can provide control of the device in one direction,with pressurization providing a force in the opposing direction. Thepressure chamber can be sealed with the base and pressurized. The baseis shown without a top for illustrative purposes. A pressure gauge 232can be attached to the pressure chamber and/or the base and can senseand display pressure therein.

Steering controls 234 can include one, two or more motors 230 therebyallowing an electronic input interface (e.g., joystick, buttons,paddles, pedals) to control the deployment of the elongated element 237.Another motor can provide axial movement for actuation of the distalcomponent of the elongated element, for actuation of tools at the distalcomponent and/or for steering and other motion (e.g., vibration,rotation, drilling) of the distal component itself. The base can havefeed through ports 236 for example to feed tools such as electronicsand/or mechanical devices through the elongated element. The feedthrough ports can be configured so the tools can be transitioned to orfrom a pressurized region from or to a non-pressurized (e.g., outside)region without pressure leakage. The feed through ports can negate theneed for a base seal around the elongated element, shaft, but a baseseal can still be used in addition to the feed through ports.

FIG. 50 a illustrates that the base can be in fluid communication with afluid control system 240. The base, for example at the base pressureport, can be connected to a pressure delivery line 256. The pressuredelivery line can be connected to an outgoing second valve and/or anincoming first valve.

The first valve 242 can be configured to open manually and/orautomatically. The first valve can open when the tube pressure exceeds amaximum desired tube pressure. The first valve can be connected to avacuum pump 244. The vacuum pump can be activated to deflate the tubeand withdraw the tube or reduce the tube pressure. The vacuum pump canbe attached to an exhaust tank 246 and/or directly to a bleed or drainline 248. The exhaust tank can be connected to the drain line, forexample to exhaust overflow from the exhaust tank.

Controls 250 can be in data communication with the first valve and thesecond valve. The controls can be on the base (e.g., a button or switchon the base).

The second valve 252 can be attached to a pump 260, for example acylinder 262 with a displacement component 264, such as a piston. Apressure regulator 254 can be in the flow path between the pump and thesecond valve. The pressure regulator and/or the first valve can open andrelease pressure from the pump when the tube pressure exceeds a maximumdesired tube pressure.

An intake tank 258 can be fed in line (as shown) or through the pump tothe second valve, for example through the pressure regulator. The fluidin the intake tank can be fed into the pressurized tube. The intake tankcan have a fill line 266 for filling the intake tank with fluid. Thefill line can be fed directly to the second valve, pressure regulator orpump without the intake tank.

The biological navigation device can have capital equipment which canprovide utility to the remainder of the device. The capital equipmentcan include, for example, the elements in the fluid control system. Thefluid control system can have a fluid source (e.g., the intake tankand/or fill line), a pressurize source such as the pump, a conduit fordelivery of the pressurization media (e.g., the pressure delivery line),controls, system monitoring elements (e.g., can be in the controls). Thecapital equipment can reduce the profile of the tube, for example, inwhich tools can be inserted. The integrated tools can create elementsthat reduce waste, thereby allowing for higher value capture and lessrefuse.

The fluid pressurization can be controlled by a variety of user inputs,for example a button on the elongated element or base, voice commands,foot pedals, or combinations thereof.

FIG. 50 b illustrates that an extensible displacement member, such as apiston, can be used to pressurize the deployment system. A fluid supply268 can be attached to the inlet port, for example via connecting tubing270. The inlet port 272 can have a one-way (i.e., check) valvepreventing backflow. The outlet port can have a one-way (i.e., check)valve preventing backflow. The fluid supply can be filled with fluid.The fluid can be delivered to the deployment system under no pressure orpositive pressure. The pump can be separate from or attached to theinlet port. For example, the fluid supply can be routed through the pumpbefore or after passing through the inlet port and into the deploymentsystem.

FIG. 51 illustrates that the colonoscope can be positioned before entryinto the colon, for example via the rectum after passing the anus 12.FIG. 52 illustrates that the pressure in the everting element cavitiescan be increased and/or the colonoscope can be otherwise deployed, andthe colonoscope can translate, as shown by arrow, into the rectum 14.

The colonoscope is shown having an outer diameter smaller than the innerdiameter of the colon for exemplary purposes. The colonoscope can havean outer diameter about equal to the inner diameter of the colon. Forexample, the colonoscope can have an inflatably expandables evertingelement that can flexibly expand to substantially fill the cross-sectionof the length of the colon occupied by the colonoscope.

FIG. 53 illustrates that the distal end of the colonoscope can activelyor passively flex in a cone of motion, with one portion of that plane ofmotion depicted by the arrow. The distal end of the colonoscope canactively rotate, for example by actuation of control wires and/oractuators in or attached to the tip.

The distal end of the colonoscope can passively rotate, for example ifthe colonoscope (e.g., the everting element, such as the everting frontand/or the everting element outer section) contacts a wall of the colon(e.g., the superior wall of the rectum).

FIG. 54 illustrates that after making a turn in the rectum the distalend of the colonoscope can be further extended, as shown by arrow, ortranslated into and through the sigmoid colon 16, for example as theeverting element continues to evert.

FIG. 55 illustrates that the colonoscope can make a turn, as shown byarrow for example as the colonoscope passes from the sigmoid colon tothe descending colon 18. FIG. 56 illustrates that the colonoscope can befurther advanced, extended or translated, as shown by arrow, for exampleby everting the everting element, through the descending colon after thecolonoscope has made two previous turns.

The colonoscope can be repeatedly turned and advanced, for example byeverting the everting element, to extend as far along the colon asdesired.

At any length in the colon, the colonoscope, for example at the tip, cangather diagnostic (e.g., sensing) data, such as data for visualization,tissue inductance, RF absorption or combinations thereof. Thecolonoscope can also gather tissue samples (e.g., by performing a biopsyor removing a polyp). At any length in the colon, the colonoscope, forexample at the tip, can perform treatment or therapy, such as deliveryof a drug onto or into tissue, tissue removal (e.g. polyp or tumorremoval), or combinations thereof.

FIG. 57 illustrates that the colonoscope can be advanced along theentire colon, passing through the rectum 14, sigmoid colon 16,descending colon 18, transverse colon 20, ascending colon 72, and havingthe tip distal end in the cecum 24. The colonoscope can be withdrawn, asshown by arrows, from the colon, for example by applying a tensile forceagainst the everting element outer section, as shown by arrows. Thecolonoscope can be withdrawn, as shown by arrows 274, from the colon,for example by applying a tensile force to the umbilical(s).

The colonoscope (e.g., the tube) can be made from PTFE (Teflon), ultrahigh molecular weight polyethylene (UHMW), LDPE, FEP, nylon copolymer(such as Nylon 6), a thermoplastic elastomer (TPE), such as Santoprene,Flexible PVCs (FPVCs), or combinations thereof. For example, the tubeand/or the sheath can be made from PTFE. The tube can be made as acomposite or reinforced structure. The colonoscope (e.g., the tube) canbe made from a material that can have unidirectionally orientedproperties, such as directional tear properties. The directional tearproperty can be augmented by applying preferential tear locationproperties, such as scoring or skirting. A blade can be run partiallythrough the tube wall, such that the wall can tear with less force andin a more predictable location. The colonoscope (e.g., the tube) can bemade from materials that are not unidirectionally oriented, for examplethose with effective tear properties (e.g., those that have, beenscored). The colonoscope can be made from a highly lubricious material.The colonoscope and elements thereof can be made from RF weldingadditives to a substrate, such as a LDPE substrate. The colonoscope(e.g., the tube) can be made from a readily bondable material, and/or alow friction material, and/or biocompatible materials, and/or flexiblematerials.

The colonoscope (e.g., the tube) can be made from layflat tubing. Thecolonoscope (e.g., the tube) can be tear and puncture resistant. Thecolonoscope (e.g., the tube) can be lubricious during use. Any elementsof the colonoscope can be extruded as one continuous element or multiplejoined elements. The colonoscope elements can be heat joined tubing,sheet, extrusions, and combinations thereof. The colonoscope elementscan be bonded, heat joined, RF welded, or connected by other methodsknown in the art.

The colonoscope can have inlaid deformable members in the tube. Thereinforcements can be inlaid deformable members. For example, theeverting element, sheath, reinforcements, other tube wall, orcombinations thereof, can be or have one or more deformable aluminumfibers, filaments, ribbons, beams, or combinations thereof. Thedeformable members can be made from a metal, for example aluminum, NiTialloy, or combinations thereof.

Still or motion rearward (i.e., proximal), forward (i.e., distal), side(i.e., lateral) images can be captured from the tip (e.g., from one ormore CMOS chips, other cameras, and/or optical fibers). Still or motionview about 360° around the tip can be captured. The rearward and forwardimages can be concurrently viewed (e.g., on a split screen or with aninset vie % on one monitor or with separate dedicated monitors), orexclusive of one another (the ability to switch back and forth betweenthe views).

A full, locationally-indexed mosaiced image of the entire inside of thecolon can be created. The visualization (and other) data can then bearchived and referenced at a later date, for example to compare polypgrowth and other changes that could indicate biologically relevantphenomenon. Locational indexing can be created by comparing x,y,z tiplocations from a tip sensor to an outside-placed sensor detectingelement. Axial location can be recorded, for example by measuringplay-out from the anal entry point.

The tip body and/or tip distal end can have the umbilical(s) connectedthereto and extending proximally therefrom.

The colonoscopy system can be manually and/or actuator controlled.Control inputs can be delivered through a manually actuated controllablemodule, such as a joystick (e.g., for tip control) and/or a series oflinear and rotary potentiometers and switches. The colonoscopy systemcan be programmed to be controlled by voice commands. The colonoscopysystem can be controlled by a foot pedal (e.g., for tube extension ortranslation), and/or a combinational interface (e.g., hand controlled),for example for tip control. The user interface can be attached as partof the deployment system, and/or the user interface can be a controlunit that is attached by wires to the deployment system, and/or the userinterface can communicate wirelessly with the remainder of thecolonoscopy system.

The colonoscope tube (e.g., everting element) can be made from anunsupported plastic film, PET, any other material disclosed herein, orcombinations thereof. The colonoscope tube can be reinforced, such as bymetal filaments or fibers, or a metal mesh.

Any or all elements of the colonoscope system and/or other devices orapparatuses described herein can be made from, for example, a single ormultiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol),cobalt-chrome alloys (e.g., ELGILOY® from Elgin Specialty Metals, Elgin,Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.),nickel-cobalt alloys (e.g., NP35N® from Magellan Industrial TradingCompany, Inc., Westport, Conn.), molybdenum alloys (e.g., molybdenum TZMalloy, for example as disclosed in International Pub. No. WO 03/082363A2, published 9 Oct. 2003, which is herein incorporated by reference inits entirety), tungsten-rhenium alloys, for example, as disclosed inInternational Pub. No. WO 03/082363, polymers such as polyethyleneteraphthalate (PET), polyester (e.g., DACRON® from E. I. Du Pont deNemours and Company, Wilmington, Del.), polypropylene, aromaticpolyesters, such as liquid crystal polymers (e.g., Vectran, from KurarayCo., Ltd., Tokyo, Japan), ultra high molecular weight polyethylene(i.e., extended chain, high-modulus or high-performance polyethylene)fiber and/or yarn (e.g., SPECTRA® Fiber and SPECTRA® Guard, fromHoneywell International, Inc., Morris Township, N.J., or DYNEEMA® fromRoyal DSM N.V., Heerlen, the Netherlands), polytetrafluoroethylene(PTFE), expanded PTFE (ePTFE), polyether ketone (PEK), polyether etherketone (PEEK), poly ether ketone ketone (PEKK) (also poly aryl etherketone ketone), nylon, polyether-block co-polyamide polymers (e.g.,PEBAX® from ATOFINTA, Paris, France), aliphatic polyether polyurethanes(e.g., TECOFLEX® from Thermedics Polymer Products, Wilmington, Mass.),polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinatedethylene propylene (FEP), absorbable or resorbable polymers such aspolyglycolic acid (PGA), poly-L-glycolic acid (PLGA), polylactic acid(PLA), poly-L-lactic acid (PLLA), polycaprolactone (PCL), polyethylacrylate (PEA), polydioxanone (PDS), and pseudo-polyamino tyrosine-basedacids, extruded collagen, silicone, zinc, echogenic, radioactive,radiopaque materials, a biomaterial (e.g., cadaver tissue, collagen,allograft, autograft, xenograft) any of the other materials listedherein or combinations thereof. Examples of radiopaque materials arebarium sulfate, zinc oxide, titanium, stainless steel, nickel-titaniumalloys, tantalum and gold.

The systems, devices, elements and methods disclosed herein can be usedin conjunction or substituted with any of the systems, devices, elementsand methods disclosed in Provisional Patent Application Nos. 60/887,323,filed 30 Jan. 2007; and 60/949,219, filed 11 Jul. 2007; and PCTApplication Nos. PCT/US08/52535, filed 30 Jan. 2008; and PCT/US08/52542,filed 30 Jan. 2008, which are all incorporated herein by reference intheir entireties. The everting element can be merely representative ofany pressurized tube, including those disclosed in the referencesincorporated, supra.

The term colonoscope is used for exemplary purposes and can be anydeployable elongated element for use in a body lumen, such as anendoscope. The pressurizer can be the deployment system. The terms tip,tool tip, tip distal end, and tool head are used interchangeably herein.Any elements described herein as singular can be pluralized (i.e.,anything described as “one” can be more than one). Any species elementof a genus element can have the characteristics or elements of any otherspecies element of that genus. The above-described configurations,elements or complete assemblies and methods and their elements forcarrying out the invention, and variations of aspects of the inventioncan be combined and modified with each other in any combination.

1. A device for navigation through a biological lumen comprising: afirst everting tube having a long axis, wherein the first everting tubecomprises a tube wall, and wherein the tube wall is controllablytearable substantially in the direction of the long axis; and a channelconfigured to receive a tool, wherein the channel extends along the longaxis.
 2. The device of claim 1, wherein the channel is formed by theinside of the first everting tube.
 3. The device of claim 1, wherein thechannel is a virtual space.
 4. The device of claim 1, wherein a seam isformed in the first everting tube, and wherein the controllable tearfollows the seam.
 5. The device of claim 4, wherein the seam comprisesperforations.
 6. The device of claim 1, further comprising a secondeverting tube, and wherein the first everting tube is inside the secondeverting tube
 7. The device of claim 6, wherein the second everting tubeis configured to be pressurized.
 8. A device for navigation through abiological lumen comprising: an everting tube having an inside and anoutside; and a conduit having a channel formed within the conduit, andwherein the channel is configured to receive a tool for use in thebiological lumen, and wherein the conduit is configured to releasablyattach to the tool, and wherein the conduit is on the outside of theeverting tube.
 9. The device of claim 8, wherein the conduit isresilient.
 10. The device of claim 8, wherein the conduit is attached tothe outside of the everting tube, along a long axis of the evertingtube.
 11. The device of claim 8, wherein the conduit comprises a malestandoff geometry.
 12. The device of claim 8, wherein the conduitcomprises an extruded configuration integral with the everting tube. 13.The device of claim 8, wherein the conduit, comprises two opposed andoffset fingers, wherein the at least two fingers are resilient, andwherein the fingers are configured to resiliently deform to allow theegress of the tool out of the channel.
 14. A device for navigationthrough a biological lumen comprising: an everting tube having an insideand an outside; a first conduit having a sidewall, wherein the firstconduit is fixed to the outside of the everting tube along the long axisof the everting tube, and wherein the first conduit comprises an openslot along a length of the sidewall, and wherein the open slot issubstantially parallel with the long axis of the first conduit, andwherein the first conduit is configured to releasably attach to a toolfor use in the biological lumen.
 15. The device of claim 14, wherein theopen slot is configured to release the tool from attachment to the firstconduit.
 16. The device of claim 14, wherein the first conduit isintegral with the everting tube.
 17. The device of claim 14, wherein thefirst conduit further comprises a male configuration integral fixed tothe sidewall, wherein the male configuration is substantially along thelong axis of the sidewall, and wherein a length of the maleconfiguration is configured to engage a length of the first conduit. 18.The device of claim 17, wherein a length of the male configuration isconfigured to engage the length of the first conduit through the openslot.
 19. The device of claim 14, wherein the sidewall is resilient.